Clinical trial · Interventional
A Prospective Study on the Prediction Model of Para-aortic Lymph Node Metastasis
A Prospective Study on the Application of Para-aortic Lymph Node Metastasis Prediction Model in Locally Advanced Cervical Cancer and Its Effect on Prognosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this prospective single-arm trial is to investigate the accuracy and feasibility of the para-aortic lymph node metastasis prediction model in locally advanced cervical cancer, as well as its impact on patients' prognosis. The main questions it aims to answer are: * Is the para-aortic lymph node metastasis prediction model accurate and feasible? * Whether the para-aortic lymph node metastasis prediction model can affect the prognosis of patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| surgical staging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- locally advanced cervical cancer treated with surgical staging
- interventionNames
- Procedure: surgical staging
Primary outcomes (1)
- measure
- The accuracy of the prediction model
- timeFrame
- 2 years
- description
- The performance of the model was assessed with respect to discrimination which was measured by the concordance index and calibration which was assessed by the calibration curve, Hosmer-Lemeshow test and Brier score. The investigators will calculate respectively the sensitivity and 95% confidence interval (CI), specificity and 95% CI, positive likelihood ratios (LR+) and 95% CI, negative likelihood ratios (LR-) and 95% CI, and the Kappa value.
Secondary outcomes (3)
- measure
- PFS
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * In 2018, the International Federation of Obstetrics and Gynecology (FIGO) stage was Ib3 IIA2-IVA; * It was treated initially without surgical and chemotherapy. * Squamous cell carcinoma, adenocarcinoma and adeno-squamous cell carcinoma were confirmed by histopathology. * Pelvic MRI ± abdominal CT or MRI or PET/CT were performed before treatment. * ECOG score:0 \~ 1. * The expected survival time\>6 months; * There is no absolute contraindication of surgery and and chemoradiotherapy and the patients with good compliance. Exclusion Criteria: * History of immune disease who need to take immunosuppressive drugs. * History of serious mental illness and brain functional disorder. * Other malignancies were diagnosed within five years or needed treatments. * Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements. * Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians. * Patients who cannot understand the research regimen and refuse to sign the informed consent form. * Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
References
Publications (0)
Data not yet available